Insulin Syringe— 510(k) K223453

Name: FDA 510(k) clearance K223453
Creator: U.S. Food and Drug Administration
Published: 2023-03-02

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K223453 for Insulin Syringe, Substantially Equivalent on 2023-03-02. Applicant: Promisemed Hangzhou Meditech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2022-11-16
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMF

view all

K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray2026-08-25
K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)2026-08-14
K260208 — Ultra-Fine SAFETY Insulin Syringe2026-07-13
K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18

More clearances from Promisemed Hangzhou Meditech Co., Ltd.

view all

K261719 — Promisemed X-Safety Pen Needle2026-08-25
K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12
K261045 — Verifine Safety Lancets2026-05-01
K254273 — Verisafe Safety Sterile Needles (SSN)2026-04-16
K250192 — Verisafe Safety Retractable Insulin Syringes2025-12-10

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.